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Senior Clinical Research Coordinator
1 month ago
Job Summary:
We are seeking a highly skilled and experienced Senior Clinical Research Coordinator to join our team at Aquent. As a key member of our clinical trials team, you will be responsible for managing and overseeing the day-to-day operations of clinical trials, recruiting and screening study participants, and documenting and reporting on the daily operations of assigned trials.
Key Responsibilities:
- Manage and oversee the day-to-day operations in the administration of clinical trial activities at the site-level
- Regularly interface with current and potential clinical trial participants to determine eligibility and consent of study participants in alignment with clinical trial protocol
- Create standard operating procedures (SOPs) that adhere to all Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations
- Contribute to the training of clinical trial staff and be accountable for compliance with the operational requirements of the clinical trial
- Function as participants' primary point of contact, keeping them informed on the study progress, and facilitate involvement of other study team members, as needed
- Manage participant visit scheduling and technical troubleshooting, escalating issues to the appropriate individual(s)
- Solicit and record information regarding safety events and prepare safety event documentation for review by the Principal Investigator
- Provide accurate and timely data collection, documentation, entry, and reporting in both Sponsor and Walgreens databases
- Support the regulatory staff in the maintenance of regulatory documents in accordance with Walgreens SOPs and applicable regulations
- Communicate and collaborate specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants
- Maintain regular contact with the Principal Investigator and team to review study details, such as progress, adverse events, and enrollment
- Maintain study supplies and issue appropriate participant stipends
- Ensure appropriate credentialing and training of the study team
- Facilitate meetings with the study monitors, auditors, and investigators
- Ensure timely response to queries and documentation of study-related issues
- If applicable, disburse investigational product, manage inventory of equipment and study supplies, and provide patient education regarding administration, as necessary
- Contribute to the development and implementation of tools, processes, and training to enhance the administration and execution of clinical studies
- Be accountable for site compliance with subject safety reporting and escalate issues
- Demonstrate professionalism and apply basic leadership practices in all aspects of the role
- Train and support study team members on a range of communication and teamwork best practices
- Perform other duties related to the clinical trials as delegated by the Principal Investigator
Requirements:
- 3-5 years of experience in clinical trial space
- Proficiency in ICH-GCP, US CFR, and HIPAA regulations
- Demonstrated ability to work independently, make informed decisions, and drive clinical trials forward
- Track record of managing multiple clinical trials simultaneously with meticulous attention to detail
- Strong prioritization skills, adept at meeting deadlines, and flexible in adapting to shifting priorities
- Proficiency in phlebotomy (certification not mandatory)
Preferred Qualifications:
- Experience with decentralized/hybrid clinical trials
Compensation:
The target hiring compensation range for this role is $50.46 to $56.06 an hour. Compensation is based on several factors, including education, relevant work experience, relevant certifications, and location.
